Kornimate/medical-research-clean huggingface dataset:
therapies for treatment-resistant panic disorder symptoms

Conditions: Panic Disorder

Summary: this study will determine the effectiveness of different treatments for panic disorder symptoms in individuals who still have symptoms after initial treatment with medication.

panic disorder is a serious condition that may cause significant psychological and physical distress. many patients with panic disorder remain symptomatic despite initial intervention. unfortunately, little data is available to guide health care providers in "next-step" treatment approaches. this study will evaluate the effectiveness of treatments for individuals with panic disorder that is resistant to initial treatment with selective serotonin reuptake inhibitors (ssris). this study will last 24 weeks and will comprise three phases. in phase 1, participants will receive the ssri sertraline for 6 weeks. phase 1 will be used to determine participants' resistance to treatment. during phase 1, participants will begin a medication schedule and symptom diary and will have weekly study visits to assess regimen adherence and any side effects they may be experiencing. in phase 2, participants will be randomly assigned to 6 weeks of one of two treatments: sertraline at an elevated dose from that given in phase 1 or a sertraline and placebo regimen. during phase 2, participants will have 3 study visits. self-report scales and diary entries will be used to assess panic disorder symptoms and medication side effects. in phase 3, participants will be randomly assigned to receive either cognitive behavioral therapy (cbt) or sertraline and clonazepam for 12 weeks. all participants will have weekly study visits during phase 3. questionnaires and self-report scales will be used to assess participants at the end of phase 3. study hypothesis: combined selective serotonin reuptake inhibitors (ssris) and benzodiazepine treatment, increasing the dose of ssri, and the addition of cognitive behavioral therapy (cbt) each may have benefits for patients with panic disorder who remain symptomatic after initial treatment with ssris.

Eligibility criteria:
inclusion criteria: * diagnosis of panic disorder exclusion criteria: * history of bipolar disorder, schizophrenia, psychosis, or delusional disorders * post-traumatic stress disorder diagnosis within 6 months prior to study entry * current use of psychotropic medications * current use of cognitive behavioral therapy

Keywords: selective serotonin reuptake inhibitor anxiety pharmacotherapy cognitive behavioral therapy cbt
emotional perceptual training as a treatment for social anxiety: behavioral and neural evidence.

Conditions: Anxiety Disorders and Symptoms; Social Anxiety Disorder

Summary: the perceptual training study is a series of studies performed with the purpose of identifying a potential avenue for treatment of mood disorders, particularly anxiety-based mood disorders. the underlying theme is that neural representations may be threat-oriented, and may also be generalized to non-threatening cues by means of similarity to threatening representations. these may result in anxiety symptoms from innocuous cues. the idea behind the perceptual training is to create a divorce between the threat representations and cues which should be considered non-threatening, enhancing perceptual acuity and potentially reducing anxiety symptoms.


Eligibility criteria:
inclusion criteria: * right-handed * normal or corrected-to-normal vision exclusion criteria: * history of a diagnosed neurological or diagnostic and statistical manual of mental disorders - iv axis i disorder * currently taking prescribed psychoactive drugs, including anti-depressants or anxiolytics. * having electrically, magnetically, or mechanically activated implants (e.g. cardiac pacemakers), due to incompatibility with mri and meg systems. * pregnancy or suspected pregnancy

Keywords: social anxiety threat processing magnetoencephalography (meg)
evaluation of pharmacokinetics, safety, and preliminary efficacy of isatuximab in chinese patients with relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: primary objective: to evaluate the pharmacokinetics (pk) of isatuximab. secondary objectives: * to evaluate the safety and tolerability of isatuximab. * to assess the preliminary antitumor effect of isatuximab. * to evaluate the immunogenicity of isatuximab.

the duration of the study for an individual patient will include a screening period of up to 21 days, a treatment period of repeated 28-day cycles, and a follow-up period. end of treatment visit will be done at 30 (±7) days after last treatment.

Eligibility criteria:
inclusion criteria: * known diagnosis of symptomatic multiple myeloma. * at least 2 prior lines of therapies which must include treatment with at least 1 of an immunomodulatory drug (imid) or a proteasome inhibitor (pi). the patients must have received an imid or a pi for ≥2 cycles or ≥2 months of treatment. * patients must have been responsive to at least 1 prior line of therapy (minimal response or better). * refractory to the most recently received imid or pi included therapy (ie, patients must have progressed during or within 60 days of completion of treatment with imid or pi). for patients who have received more than 1 type of imid or pi, their disease must be refractory to the most recent one. * measurable disease defined as at least 1 of the following: * serum m-protein ≥0.5 g/dl (≥5 g/l); * urine m-protein ≥200 mg/24 hours. * written informed consent. exclusion criteria: * \<18 years old. * eastern cooperative oncology group (ecog) performance status \>2. * life expectancy of less than 3 months. * pretreated with any anticluster of differentiation (cd) 38 agent. * concurrent plasma cell leukemia. * known amyloidosis. * disease measurable only by serum free light chain (flc) analysis. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: anti-cd38 monoclonal antibody
evaluation of the brain activity during spinal cord stimulation in failed back surgery syndrome using functional mri and mrs

Conditions: Failed Back Surgery Syndrome

Summary: functional magnetic resonance imaging (fmri)and mr spectroscopy of the brain are perfect tools to investigate the changes in the brainstem and brain evoked by the orthodromically impulses of a scs.

in case a patient meets all inclusion and no exclusion criteria, he/she will be implanted with an epidural neurostimulation lead (electrode). the day of implant will be recorded as day 0 (table 1) and will always be a thursday. post lead implant, the patient will be hospitalized for a small week as per common practice in case of the intervention outside of the study. during hospital stay, the investigator of the study, or a representative of the product manufacturer, medtronic®, will search for the optimal stimulation parameters to evoke correct paraesthesia coverage and pain relief. if appropriate parameters have been found, these will be saved in the external neurostimulator. after maximum one hour, the neurostimulator will be turned off again. on day 12, a tuesday, a mr spectrospoy will be performed. each patient will undergo three sessions. each session will be divided into a mr spectroscopy session and fmri session without stimulation and a session with stimulation. the mr spectroscopy session without stimulation will bring us the baseline in neurobiology of neuropathic pain; after measurement, the stimulator will be switch on and a mr spectroscopy will be performed during a longer period of time (10 min) in order to determine neurobiological changes in time during scs. the 3 mr spectroscopy sessions will be performed on different regions in the brain (both talami and rostral region of anterior cingulated cortex)

Eligibility criteria:
inclusion criteria: 1. age male/female patient ≥ 18 years 2. patient diagnosed with failed back surgery syndrome with at least one prior spinal surgery 3. patient with low back pain and/or pain in at least one leg 4. pain intensity at baseline assessed by vas \> 5 (50%) 5. patient willing to provide informed consent. exclusion criteria: 1. use of spinal cord stimulation in this patient in the past. 2. presence of other clinically significant or disabling chronic pain condition 3. expected inability of patients to receive or properly operate the spinal cord stimulation system 4. history of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus bechterew 5. active malignancy 6. current use of medication affecting coagulation which cannot be temporarily stopped 7. evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator 8. life expectancy of less than 1 year 9. existing or planned pregnancy 10. existing extreme fear for entering mri

Keywords: fbss at least one prior spinal surgery
a pilot study to explore the role of gut flora in rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Arthritis, Rheumatoid; Arthritis

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding rheumatoid arthritis

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients of any age (interest is given to children to compare with mothers). 3. diagnosis of rheumatoid arthritis exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
a study to determine the maintenance of effect after long-term treatment of sativex® in subjects with neuropathic pain

Conditions: Pain; Peripheral Neuropathy

Summary: the purpose of this study is to assess the maintenance of effect after long-term treatment of sativex® in subjects with neuropathic pain.

a five week randomised-withdrawal phase (part b) for a subset of subjects who took part in a 38 week, multicentre, open label (part a) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, sativex® in the treatment of subjects with neuropathic pain. subjects returned to the centre for an end of treatment visit at week 38 of part a (visit 5, day 266), followed by visits 5b (week 39), 5c (week 43) and an end of study visit took place 28 days after visit 5c or withdrawal from the study.

Eligibility criteria:
inclusion criteria: * had participated in gwcl0404, was currently ongoing in the study (i.e. still receiving gw-1000-02 treatment) and had completed the study up to visit 5 * had complied with all of the study requirements to-date, including the completion of the diary cards * had shown tolerability to the study medication in this study * ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires exclusion criteria: * had experienced or was currently experiencing any adverse events or untoward medical occurrences which, in the opinion of the investigator, would prevent them from safely participating in this phase of the study

Keywords: pain peripheral neuropathy
effect of virtual reality on patients with acute pain after thoracoscopic surgery

Conditions: Virtual Reality; Acute Postoperative Pain; Thoracic Surgery, Video-Assisted

Summary: immersive virtual reality (vr) as a non-pharmaceutical technology may deliver effective behavioral therapies for postsurgical patients with acute pain. to determine the analgesic effects of vr on patients after thoracoscopic surgery. the investigators conducted a randomized clinical trial to determine the postoperative effect of vr on pain relief in patients undergoing thoracoscopic surgery.

immersive virtual reality (vr) as a non-pharmaceutical technology may deliver effective behavioral therapies for postsurgical patients with acute pain. patients in the qtc-vr group had to participate in 15-minute interactive games wearing 3d-vr headsets. qtc-vr intervention had functions for breath-relaxation and attention-concentration training. it instructed the patients to breathe deeply with the marine animal's swimming relaxation rhythm and to constantly switch the vision field by rotating their heads and necks to catch animals. therefore, the investigators conducted a randomized clinical trial to determine the postoperative effect of qtc-vr on pain relief in patients undergoing thoracoscopic surgery.

Eligibility criteria:
inclusion criteria: 1. the patient's age is ≥ 18, regardless of gender. 2. within one day after thoracoscopic surgery. 3. the nrs of postoperative pain is ≥ four. 4. having specific internet knowledge and mobile phone reading and writing abilities. 5. patients voluntarily sign the informed consent form and are willing to complete the follow-up according to the trial protocol. exclusion criteria: 1. patients have severe cognitive disorders. 2. patients with previous diagnoses of epilepsy, dementia, migraine, or other neurological diseases may have difficulty using the vr headset. 3. patients are sensitive to light stimulation. 4. patients are without stereopsis or with severe hearing impairment. 5. patients with trauma to the eyes, face, or neck are not comfortable using vr headsets. 6. patients have severe heart, liver, kidney, blood, digestive, and nervous diseases. 7. patients previously used the vr headset but found it ineffective. 8. patients have a history of severe alcoholism, long-term heavy drinking, and symptoms of alcohol dependence. 9. patients have participated in any analgesic intervention study in the past week. 10. women have pregnancy plans during the follow-up period of the study. 11. patients and their families work in digital health or pharmaceutical companies for acute or chronic pain management. 12. patients cannot use electronic devices such as smartphones.
post-stroke improvement of motor function

Conditions: Cerebrovascular Accident

Summary: open-label clinical study where all new patients presenting with cerebrovascular accidents and consenting to treatment are given intravenously a new combination of medications. patients are evaluated neurologically with nihss scores before treatment administration and at 1 month after the first treatment. further evaluations at 6 months after treatment by nihss and barthel scores are ongoing

patients with cerebrovascular accidents (cva), ischemic (including those with hemorrhagic transformation), are given a new combination of medications which aims to improve neuronal survival, stimulate mitochondrial genesis and the formation of new synapses. this combination is given as an intravenous perfusion with a 2-hr duration and consists of vitamins b1, b6, b12, c, actovegin, etc. before treatment a nihss score is given. each patient receives 3-4 such perfusions in 1 month and afterwards another nihss score is obtained. patients are monitored afterwards and those who show improvements receive more such treatments, and new nihss and barthel scores are obtained. patients are grouped on the basis of the time interval between cva occurence and first treatment: * group 1: 0-35 days * group 2: 36-100 days * group 3: 101-360 days improvement of motor function is compared using nihss scores between groups, and between literature and groups

Eligibility criteria:
inclusion criteria: * adults with cva * agreeing to treatment in person or by proxy signing of informed consent form * available for nihss evaluation exclusion criteria: * allergy to any of the substances administered * scheduled for surgery or other procedures * not available for nihss evaluation after at least 48 hours from treatment
strategy of transfusion in trauma patients - stata trial

Conditions: Wounds and Injuries

Summary: the purpose of this study is to compare two already validated methods for massive transfusion in trauma patients admitted to the emergency room of a large reference hospital.

in this randomized trial trauma patients in need of massive transfusion will be assigned to one of the following transfusion strategies: 1. - fresh frozen plasma, platelets concentrate and packed red blood cells in 1:1:1 ratio. 2. - these patients will receive red blood cells based on haemoglobin measurements and will receive either beriplex® p/n (csl behring gmbh, marburg, germany) or haemocomplettan® p (csl behring, marburg, germany), or platelets based on thromboelastometry. to be included patients must meet the following inclusion criteria: 1. - trauma victims 2. - adults between 18 - 80 years old 3. - injury severity score (iss) between 15 and 45 4. - assessment of blood consumption (abc) score ≥ 3 points 5. - shock index ≥ 1,2 6. - acute hemorrhage of more than 50% estimated blood volume in 3 hours or more than 1,5 ml/kg/min of blood during 20 minutes. exclusion criteria: 1. - early cardiac arrest 2. - pregnancy 3. - injury severity score (iss) \> 45 4. - patient transferred from another hospital 5. - drug abuse history 6. - known coagulation impairment 7. - known use of anticoagulants, or platelet antiaggregants. the group of health-care providers recruiting the patients based on eligibility criteria, is different than the group that evaluates the clinical outcomes of the included patients, in such a way that no researcher is tasked with post-randomisation care of the subjects. this is done to prevent observational bias. two informed consent forms are signed for each patient. the first one is signed by an independent physician. another consent form is signed by the patient's family or the own patient within 24 hours of hospital admission. the randomisation is performed by sealed envelopes assigned to the eligible patients anytime they reach the protocol criteria. the envelopes were created using a computer generated randomisation table specifically designed to this study. an interim analysis was performed in october 2015 and it showed that there was no increased mortality or morbidity within the intervention group.

Eligibility criteria:
inclusion criteria: * trauma victims * adults between 18 - 80 years old * injury severity score (iss) between 15 and 45 * assessment of blood consumption (abc) score ≥ 3 points * shock index ≥ 1,2 exclusion criteria: * early cardiac arrest * pregnancy * iss \> 45 * patient transferred from another hospital * drug abuse history * known coagulation impairment * known use of anticoagulants, or platelet anti-aggregants. -

Keywords: thrombelastography massive transfusion major trauma blood products thromboelastometry
maximizing native arteriovenous fistulae rates.

Conditions: Kidney Failure; Arteriovenous Shunt; Hemodialysis

Summary: the purpose of our study is to compare physical examination alone to color doppler ultrasonography (cdus) vascular mapping and physical examination in terms of outcomes of vascular access and long-term patency.

fistula maturation is a complex vascular remodelling process that requires vessel dilation, increases in volume flow rates in the feeding artery and afferent vein and structural alterations of the vascular wall. the understanding of these procedures and the factors involved in promoting maturation is limited. in this context, one of the major areas requiring investigation is the identification of clinically useful pre-operative predictors of access outcome. traditionally, the selection of vascular access and the eligibility for native arteriovenous fistula construction was mainly determined by findings of clinical examination. however, in addition to a complete history and physical examination, national kidney foundation/dialysis outcome quality initiative (nfk/doqi) recommended that routine pre-operative color doppler ultrasonographic vascular mapping should be performed in all hemodialysis patients who are candidates for access formation. this concerns the routine implementation of a non-invasive, safe and cost-effective method that permits the identification of vessels that are suitable for arteriovenous fistula (avf) construction, acknowledging that supporting level i evidence is still lacking. indeed, available data supporting the significance of mapping on access maturation and patency rates are limited and conflicting. the aim of the present study is to compare the type of preoperative assessment, physical examination alone to combined cdus vascular mapping and physical examination, to outcomes of performed vascular access procedures with respect to type selection and long-term patency at 12 months in hemodialysis patients.

Eligibility criteria:
inclusion criteria: * end stage renal disease exclusion criteria: * poor life expectancy * congestive heart failure new york heart association stage 3 and over * candidates for tunneled catheters

Keywords: arteriovenous fistula colour doppler physical examination renal dialysis retrospective studies
a double blind placebo controlled study to assess the efficacy on joint damage in ra patients

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to assess the efficacy on joint damage and safety in ra patients treated with dmards in a double blind, placebo controlled study.


Eligibility criteria:
inclusion criteria: * clinically diagnosed as rheumatoid arthritis by the revised acr criteria * those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine * those who have at least one erosion on x-ray of hands, wrists or feet exclusion criteria: * those who have been treated with any biologic drugs or leflunomide * those who meet class 4 with the steinbrocker functional classification

Keywords: tacrolimus rheumatoid arthritis tacrolimus anhydrous
chlorhexidine and essential oil mouthwashes on human beta-defensin 2 (hbd2) and kathelicidin (ll-37) saliva levels

Conditions: Mouth and Tooth Diseases; Periodontal Diseases; Gingivitis

Summary: recent studies have shown that while mouthwashes exhibit antimicrobial properties against bacteria and their products, at the same time showing the cytotoxic effect on living cells in the mouth.29 to the best of our knowledge, there is no information about the toxicity effect of these two mouthwashes, which are highly preferred, on antimicrobial peptides secreted from the oral epithelium. therefore, our aim in this study is to evaluate the effect of chlorhexidine and essential oil mouthwash on hbd2 and ll-37 in saliva.

periodontal health continues with a balanced interaction of the oral microflora with the host defense line.

Eligibility criteria:
inclusion criteria: 1. systemically healthy, 2. presence of ≥20 natural teeth, 3. agreement to participate in the study . exclusion criteria: 1. known systemic illness, 2. smoking habit, 3. pregnancy/ lactation, 4. long-term use of anti-inflammatory drugs.

Keywords: periodontitis gingivitis mouthwashes